Hartmann Vivano Tec Pro - Patient Population; Dressing Removal

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Resterilization
Components of the VivanoSystem that are provided sterile are meant for single use� Do not resterilize any of these
components as it may cause overall decline in the therapeutic efficiency of the kit and potentially lead to wound
contamination and/or infection�
Safety measures for infection prevention
Implement and apply adequate personal protection and institutional infection control measures when handling the
components of the VivanoSystem (e�g� the use of sterile gloves, masks, gowns etc�)�
IMPORTANT: Before and after using the stopper on the VivanoTecPort connector, it must be cleaned and disinfected�
Patient population
No general restrictions for the usage of the VivanoSystem in different patient populations (e�g� adults and/or children)
are given� However, the VivanoSystem has not been evaluated for use in paediatrics�
IMPORTANT: Before prescribing its use on a child, weight and height along with the overall health condition must be
medically evaluated first�
Patient health status
Weight and general condition of the patient should be taken into consideration during any application of negative
pressure wound therapy�
Dressing size
The size of the dressing must be adapted to the size of the wound being treated with the negative pressure wound
therapy�
Improper wound dressing size may either cause maceration and disintegration of the peri-wound tissue, or wound
margins drying out and inefficient transfer of exudate�
NOTE: For more information on complications related to excessive coverage of the intact skin, please refer to the Dressing
of the intact skin section of this document�
IMPORTANT: In order to provide optimal conditions for negative pressure wound therapy, the film dressing should cover
about 5cm of intact skin around the wound�
Dressing placement
Use only dressings coming directly from sterile packages�
Do not force the placement of the foam, as it may lead to direct tissue damage or subsequent wound healing delay or
even local necrosis, due to an elevated level of compression�
IMPORTANT: Always record the number of foams used for each wound� The number of layers of film in the dressing can
be adapted to each medical condition� Placement of multiple layers of film increases the risk of tissue maceration and
consequently tissue irritation�
IMPORTANT: In case of tissue irritation, due to the use of multiple layers of the film, discontinue the Vivano negative
pressure wound therapy�
Dressing removal
IMPORTANT: Always record the number of foams removed from the wound in order to guarantee the removal of all
foams introduced�
Foam left in the wound for a longer period of time than indicated in the Dressing change section may cause growth of
granulation tissue into the foam� This may increase the difficulty of dressing change and may promote wound infection,
among other medical complications�
Dressing changes may possibly lead to disruption of the new granulation tissue, which may result in bleeding�
IMPORTANT: Implement additional protective measures, when changing the dressing of patients with identified
increased risk of bleeding�
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